NCT00175162

Brief Summary

The purpose of this study is to compare the early migration and periprosthetic bone changes of two total knee arthroplasties fixated with two different type bone cement.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 19, 2022

Status Verified

October 1, 2010

First QC Date

September 10, 2005

Last Update Submit

December 14, 2022

Conditions

Osteoarthritis

Keywords

RSADEXAGenoarthrosisKnee ArthroplastyMicromotion of polyethylene linerCement

Outcome Measures

Primary Outcomes (1)

  • Tibial prosthesis part migration evaluated by RSA.

    2011

Secondary Outcomes (1)

  • Micromotion of the modular polyethylen liner in both type prostheses evaluated by RSA estimating the role of wear.

    2011

Study Arms (2)

Osteopal G bone cement

ACTIVE COMPARATOR
Device: Osteopal G vs. Refobacin-Palacos R bone cement

Refobacin-Palacos R bone cement

ACTIVE COMPARATOR
Device: Osteopal G vs. Refobacin-Palacos R bone cement

Interventions

Osteopal G vs. Refobacin-Palacos R bone cementDEVICE

Bone cement

Also known as: Osteopal G bone cement, refobacin-palacos R bone cement
Osteopal G bone cementRefobacin-Palacos R bone cement

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients with one- or double-sided primary knee arthrosis.
  • Patients with a sufficient bone quality for implantation of knee prosthesis.
  • Informed and written patient consent.

You may not qualify if:

  • Patients with neuromuscular or vascular diseases in the affected leg.
  • Patients who peroperatively are estimated unsuitable for knee arthroplasty e.g. due to bone cysts or dilution of the bone mass.
  • Patients who use non-steroid anti-inflammatory drugs (NSAID) and cannot refrain from taking them postoperatively (this includes COX-2-inhibitors).
  • Patients with osteoporosis estimated from the preoperative x-ray or former diagnosis of osteoporo-sis.
  • Patients with knee arthrosis following fracture sequelae.
  • Women, who are pregnant or are at risk of getting pregnant throughout the 2 year follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Center, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kjeld Søballe, MD, Prof.

    Orthopaedic Center, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C, Denmark.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 15, 2005

Study Completion

December 1, 2010

Last Updated

December 19, 2022

Record last verified: 2010-10

Locations

DK(1)